MedDRA 10012689 MedDRA 10012688
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: • Written informed consent • Patients with type 2 diabetes mellitus (T2DM) for whom datasets from the previous studies are available • Ability to understand and follow study-related instructions
Exclusion criteria
Exclusion criteria: • Acute infection within 14 days prior to screening • Acute inflammatory disease within 14 days prior to screening or current chronic inflammatory disease • Pre-existing autoimmune disease • Treatment with immune suppressive drugs within 14 days prior to screening • Systemic treatment with glucocorticoids within 14 days prior to screening • Myocardial infarction or stroke within 1 year before inclusion • Surgeries (including intravitreal injections) within the previous 3 months • Oncological disease within the previous 5 years • Women who are pregnant or breast-feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this observational study is to determine the prognostic value of traditional and new risk factors for development of DR and progression of DME, respectively. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives of the study are to • investigate the impact of quality of diabetes and risk factor control on development of FRT • identify high-risk groups for FRT and DR • develop a guide for OCT diagnostics in managed care programs | — |
Countries
Germany
Contacts
Augenklinik der Klinikum Chemnitz gGmbH